Zydus Lifesciences Secures CDSCO Panel Approval for Usnoflast Capsule Interaction Study
New Delhi: The Subject Expert Committee (SEC) on Investigational New Drugs under CDSCO has recommended approval for Zydus Lifesciences Limited to carry out a Phase I Drug-Drug Interaction (DDI) study of its investigational molecule Usnoflast (ZYIL 1) in capsule strengths of 25 mg, 50 mg, and 75 mg.
The decision came at the committee's meeting on September 4, 2025, held at CDSCO headquarters in New Delhi.
The firm presented its Phase II clinical study report (ZYIL1.23.003, Version 01, dated October 24, 2024) along with the Drug-Drug Interaction Phase I study protocol (C1B05514, Version 01, dated March 12, 2025). These submissions were made in response to earlier recommendations of the 06th/25th SEC (IND) meeting held on July 8, 2025
Usnoflast (ZYIL 1) is an oral small molecule currently under development for potential use in inflammatory and autoimmune disorders. These conditions often require long-term treatment, making it vital to establish how new drugs interact with commonly prescribed therapies. Drug-drug interaction studies are an essential part of the clinical process, helping determine whether a new treatment can be safely combined with existing medications without reducing effectiveness or increasing side effects.
.After detailed evaluation, the committee noted the Phase II outcomes and recommended that the Phase I study be conducted as per the proposed protocol.
Zydus Lifesciences is a drug major known for its innovation-driven approach. The company’s R&D efforts cover a wide spectrum of therapeutic areas, including oncology, metabolic disorders, infectious diseases, and immunology. Its ongoing focus on developing novel molecules has positioned Zydus as a significant contributor to clinical research both in India and globally.
